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Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer

NCT06704620 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2024-12-16

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if diphenhydramine can improve the effectiveness and decrease the toxicity for the treatment of advanced and metastatic Non-small cell lung cancer (NSCLC) with PD1 inhibitor plus chemotherapy.

The main questions it aims to answer are:

* Dose diphenhydramine improve the effectiveness and survival of advanced and metastatic NSCLC treated with PD1 inhibitor and chemotherapy?
* Dose diphenhydramine decrease the toxicity of PD1 inhibitor plus platinum-based chemotherapy?
* Researchers will compare patients with or without diphenhydramine to see if diphenhydramine works to improve the effectiveness and decrease the toxicity.

Participants will:

* Take standard treatment (tislelizumab and platinum-based chemotherapy) with/without diphenhydramine（20mg qd d0-2）every cycle.
* Visit the clinic once every six weeks for checkups and tests
* Keep a diary of their symptoms and survival visit based on the protocol.

Conditions

  • Advanced and Metastatic NSCLC

Interventions

DRUG

Diphenhydramine

Diphenhydramine intramuscular injection 20mg qd d0-2 Q3W

DRUG

Tislelizumab

Tislelizumab intravenous infusion 200mg d1

DRUG

Pemetrexed

Pemetrexed intravenous infusion 500mg/m2 d1

DRUG

Albumin paclitaxel

Albumin paclitaxel intravenous infusion 260mg/m2 d1

DRUG

Carboplatin

Carboplatin intravenous infusion AUC5 d1

DRUG

Cisplatin

Cisplatin intravenous infusion 75mg/m2 d1

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Liang Liu, M.D,Ph.D · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704620 on ClinicalTrials.gov